Tigecycline

Product NDC
63323-960
11-digit product format
633230960
Labeler code
63323
Product ID
63323-960_be02ec53-e514-4779-841b-22c6af4771af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tigecycline
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
NDA205645
Marketing category
NDA
Marketing start
2016-12-01
Marketing end
0000-00-00
Substance
TIGECYCLINE
Active strength
50 mg/5mL
Pharmacologic classes
Tetracycline-class Antibacterial [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-960-10EA - Each63323-960d56b2e61-6025-48ff-ba2c-1d8029bacb4212017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-960TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]7Legacy NDC20240228_acf5dbe5-ca75-4300-816f-b3f4625f6e7d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63323-960-106332309601010 VIAL, SINGLE-DOSE in 1 CARTON (63323-960-10) > 5 mL in 1 VIAL, SINGLE-DOSE2016-12-010000-00-00NoNoCurrent